ISPE Releases Its Oral Solid Dosage Forms Baseline Guide, Second Edition
ISPE, a global not-for-profit association of 24,000 technical professionals working in the manufacturing and drug development sectors of the pharmaceutical industry, recently announced the release of its Oral Solid Dosage (OSD) Forms Baseline® Guide, Second Edition - the latest ISPE publication reviewed by the US FDA.
"This second edition of the OSD Forms Baseline Guide is truly a compilation of the expertise and lessons-learned from some of the most seasoned and experienced industry minds as they endeavor to assist their colleagues and improve the pharmaceutical manufacturing process for oral solid dosage forms," said ISPE President and CEO Robert P. Best.
This second edition updates content from the original Oral Solid Dosage Forms Baseline® Guide to current industry standards, practices, and regulatory requirements. Specifically, it addresses the latest interpretation of GMP requirements, as well as a risk-based approach to regulatory compliance relating to the design, construction, and validation of the OSD manufacturing facility.
As with all ISPE technical documents, the OSD Baseline Guide, Second Edition utilizes a practical, pragmatic, non-theoretical approach, giving the reader guidance on solving problems and serving as a valuable tool for addressing regulatory inspections and compliance issues.
Highlights from the Table of Contents include Concepts and Regulatory Philosophy, Product Protection, Product and Processing, Process Support and Utilities, HVAC, Electrical, Control and Instrumentation, Risk-Based Approaches to Commissioning and Qualification, Cost Factors in OSD Manufacturing, Summary of Quality Risk Management Process, Risk Management Tools, and HSE International Regulations and Standards Cross References.
The first public introduction of the guide will be at the ISPE 2009 Annual Meeting Session, "Why the New OSD Guide is Vital," held on 11 November in San Diego, California, USA. The importance of the new guide will in helping pharmaceutical manufacturing professionals avoid compliance issues, improve quality, and reduce costs.
ISPE, the International Society for Pharmaceutical Engineering, is the Society of choice for 24,000 technical professionals working in or serving the manufacturing sector or drug development in the pharmaceutical industry in 90 countries. ISPE aims to be the catalyst for "Engineering Pharmaceutical Innovation" by providing Members with opportunities to develop their technical knowledge, exchange practical experience within their community, enhance their professional skills, and collaborate with global regulatory agencies and industry leaders. Founded in 1980, ISPE offers online learning opportunities for a global audience and has its worldwide headquarters in Tampa, Florida, USA; its European office in Brussels, Belgium; its Asia Pacific office in Singapore; and its newly established office in Shanghai, China. Visit www.ISPE.org for additional Society news and information.